BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUROS

    MDR report key: 4253141 · Received October 1, 2014

    Report

    Report Number
    4253141
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 1, 2014
    Manufacturer
    IVERA MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN UNSCREWED THE CUROS CAP FROM THE IV KINE AND THE INSIDE OF THE CAP WAS STILL AROUND THE LINE. RN HAD TO USE A HEMSTAT CLAMP TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610103 CUROS SET, ADMINISTRATION, INTRAVASCULAR FPA IVERA MEDICAL 002-250 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR